1. Reason for revision

The Pharmaceutical Affairs Act has been amended to introduce a notification system for the promoters of drug sales and to require the latter and their employees to receive training on the orderly sales of drugs (Law No. 19359; promulgated on April 18, 2023; implemented on October 19, 2024). The revision is designed to provide the matters delegated by the Act and the matters necessary for their implementation, such as the provision of standards and procedures for reporting the promoters of drug sales while prescribing the contents and methods of education or training for them, and prescribing the matters necessary for the designation, operation, and revocation of the training entities.

In addition, the revision is designed to improve and complement certain deficiencies revealed in the operation of the current system by clarifying the scope of the economic benefits permissible for drug suppliers, providing the basis for linking data in the expenditure report management system, and reflecting the revision to the Pharmaceutical Affairs Act in connection with the drug reexamination system (Law No. 20328; promulgated on February 20, 2024; implemented on February 21, 2025).

2. Main contents

a. Provision of reporting standards and procedures for drug sales promoters (Newly established Article 43-2 of the draft).

1) The promoters of drug sales are required to complete new training under Article 43-3 (1) 1 as the standard for declaring their business.

2) Provision of the procedures for declaring drug sales promoters or changes in, or discontinuance or suspension of, their business.

b. Provision of matters required for the training of drug sales promoters (Newly established Article 43-3 of the draft).

1) In order to maintain the orderly sales of drugs, drug sales promoters are required to undergo 24 hours of new training and 8 hours of refresher training each year.

2) Provision of the contents and methods of training, and the matters necessary for the designation, operation, and revocation of education agencies.

c. Provision of matters required for notification of the re-commissioning of drug sales promoters (Article 44 (5) of the draft).

A drug sales promoter that has been re-commissioned should notify the supplier in writing within 30 days from the date on which the re-commissioning contract is signed, and should also notify the supplier when the re-commissioning contract is modified.

d. Provision of the contents of consignment contracts (Newly established Article 44-2 (7) of the draft).

It stipulates the contents of the consignment contract, including the consignment details, such as the names of sales-consigned drugs and the fee rate for each item, and the items the consignee should comply with.

e. Provision of the basis for linking data in the expenditure report management system (Newly established Article 44-4 (2) of the draft).

It provides the basis for enabling the collection, retention, and use of necessary data and information to be obtained from the relevant central administrative agencies for the survey and disclosure of expenditure reports.

f. Provision of procedures, etc. for succession of the status of drug sales promoter (Newly established Article 59-2 of the draft).

It stipulates the procedure for succession of the status of drug sales promoter and the matters necessary for succession to such status.

g. Clarification of the scope of permissible economic benefits (Appendix 2 of the draft).

1) It clarifies the scope of economic benefits that can be provided by the promoters of drug sales. 

2) It also clarifies the standards for foods and beverages provided during product presentations to individual nursing institutions.

3) It also reflects the recent revision to the Act, including the abolition of the re-examination system for new drugs and the integration of the post-market safety management system into the risk management system.

h, Provision of standards for administrative dispositions against drug sales promoters (Appendix 3 of the draft).

It provides specific standards for administrative dispositions to be taken against drug sales promoters.